JDI · Class II · 21 CFR 888.3350

FDA Product Code JDI: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

Cemented hip replacement has decades of clinical evidence supporting its durability. FDA product code JDI covers cemented semi-constrained hip prostheses with metal and polymer bearing surfaces.

These implants use bone cement — typically polymethylmethacrylate — to fix the femoral stem and acetabular component to the surrounding bone. Cemented fixation provides immediate stability and is preferred in elderly patients with poor bone quality.

JDI devices are Class II medical devices, regulated under 21 CFR 888.3350 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Biomet, Inc., Depuy, Inc. and Howmedica Corp..

565
Total
565
Cleared
125d
Avg days
1977
Since
565 devices
97–120 of 565
Cleared Apr 04, 2002
MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS)
K020970
Biomet, Inc.
Orthopedic · 9d
Cleared Feb 27, 2002
EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER
K020291
Exactech, Inc.
Orthopedic · 30d
Cleared Jan 30, 2002
PATRIOT PROTRUSIO CAGE
K020076
Biomet Orthopedics, Inc.
Orthopedic · 21d
Cleared Dec 27, 2001
AVALON CUP SYSTEM
K011887
Orthopedic Source, Inc.
Orthopedic · 192d
Cleared Dec 17, 2001
SUMMIT CEMENTED HIP PROSTHESIS
K013352
DePuy Orthopaedics, Inc.
Orthopedic · 69d
Cleared Nov 07, 2001
MODIFICATION TO DEPUY C-STEM SYSTEM
K013350
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Oct 18, 2001
SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM
K012961
Sulzer Orthopedics, Inc.
Orthopedic · 44d
Cleared Sep 05, 2001
R120 MODULAR TOTAL HIP SYSTEM
K011774
Osteoimplant Technology, Inc.
Orthopedic · 90d
Cleared Aug 29, 2001
ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0
K012493
Exactech, Inc.
Orthopedic · 26d
Cleared Aug 27, 2001
MACROPORE IB RESORBABLE PLUG
K011715
Macropore Biosurgery, Inc.
Orthopedic · 84d
Cleared Jul 20, 2001
COLOR BUFFED (CB) DDH FEMORAL STEM
K012019
Biomet, Inc.
Orthopedic · 22d
Cleared Jul 18, 2001
BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER
K011455
Biomet, Inc.
Orthopedic · 68d
Cleared Jul 18, 2001
TRIDENT ALL POLY CUP
K012026
Howmedica Osteonics Corp.
Orthopedic · 20d
Cleared Jun 15, 2001
EXCEL FRACTURE CEMENTED HIP STEM
K011367
DePuy Orthopaedics, Inc.
Orthopedic · 42d
Cleared Jun 15, 2001
EXETER HIP SYSTEM WITH V40 TAPER
K011623
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared May 16, 2001
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1
K011218
Exactech, Inc.
Orthopedic · 26d
Cleared Apr 27, 2001
TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA
K010529
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 63d
Cleared Apr 11, 2001
LFIT V40 FEMORAL HEAD COMPONENTS
K010757
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Mar 20, 2001
MODIFICATION TO TRIDENT ALL POLY CUP
K010310
Howmedica Osteonics Corp.
Orthopedic · 47d
Cleared Mar 19, 2001
BAUMER CEMENTED HIP PROSTHESIS
K003975
Baumer, S.A
Orthopedic · 87d
Cleared Mar 19, 2001
BAUMER MULLER HIP PROSTHESIS
K003976
Baumer, S.A
Orthopedic · 87d
Cleared Feb 08, 2001
TAPER-FIT TOTAL HIP SYSTEM
K003666
Corin USA
Orthopedic · 72d
Cleared Dec 11, 2000
TRIDENT ALL POLY CUP
K001956
Howmedica Osteonics Corp.
Orthopedic · 167d
Cleared Dec 01, 2000
DEPUY C-STEM SYSTEM
K003421
DePuy Orthopaedics, Inc.
Orthopedic · 28d